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Evidence-based guidelines on orthobiologics.

Tobias Winkler1,2,3, Stephan Oehme1, Alexander Hildebrandt1,2,3,4

  • 1Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Center for Musculoskeletal Surgery (CMSC), Berlin, Germany.

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|June 3, 2025
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Summary

Orthobiologics therapies, like platelet-rich plasma (PRP) and cell-based treatments, are growing in popularity but face challenges in establishing evidence-based guidelines due to preparation and trial inconsistencies.

Keywords:
Advanced TherapiesOrthobiologicsRegenerative Therapies

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Area of Science:

  • Orthobiologics (OBs) encompass a range of regenerative medicine therapies for orthopedic conditions.

Background:

  • Blood-based (e.g., platelet-rich plasma - PRP) and tissue/cell-based (e.g., mesenchymal stromal cells) therapies are increasingly used.
  • Heterogeneity in preparation and trial quality complicates evidence-based guidelines for OBs, particularly for PRP efficacy in conditions like knee osteoarthritis.

Purpose of the Study:

  • To review the current landscape of orthobiologics therapies and the challenges in developing evidence-based clinical guidelines.
  • To highlight the need for standardized protocols and improved clinical trial frameworks for orthobiologics.

Main Methods:

  • Review of existing meta-analyses and randomized controlled trials (RCTs) for blood-based and cell/tissue-based orthobiologics.
  • Analysis of guideline development efforts by orthopedic societies (e.g., ESSKA, AAOS).

Main Results:

  • PRP shows potential for improving patient outcomes in specific orthopedic conditions, but RCTs often have high bias.
  • Cell/tissue-based therapies have longer development pipelines; while safe, evidence is less abundant than for PRP, primarily focusing on knee osteoarthritis.
  • Orthopedic societies are developing guidelines using synthesized evidence and expert consensus.

Conclusions:

  • Standardized protocols for preparation, application, and outcome measures are crucial for orthobiologics.
  • Patient stratification and robust clinical trial frameworks are essential for unlocking the full potential of orthobiologics and establishing reliable guidelines.